Hamburg, Germany Lab Expertise
Bioanalytical lab services to support customer drug development from early phase to market authorization
BioAgilytix’s advanced laboratory in Hamburg, Germany, serves as our European headquarters where we offer global customers a wide range of services, technologies, and expertise for bioanalytical support of investigative therapeutics.
Share this Resource
Copied!
Bioanalytical Laboratory Services
BioAgilytix provides PK assay development, validation, and sample testing, as well as PK analysis and reporting to support all drug modalities at any phase of development. Our site in Hamburg is equipped with the latest instrumentation and technologies for a wide range of methods, allowing us to provide custom scientific solutions to fit each of our customer’s unique PK assay needs.
Assessing a therapeutic’s immunogenicity is a key step in drug development. Our scientific teams in Hamburg have extensive expertise in the development and implementation of immunogenicity assays, including anti-drug antibody (ADA) or neutralizing antibody (NAb) assays as well as cellular immunogenicity assessments.
We offer an extensive menu of biomarker assay services from validated, ready-to-use methods to de novo assay development. Our biomarker capabilities include a variety of platforms and techniques, can be single or multiplexed, and can be qualified or validated according to the intended purpose.
Chemistry, Manufacturing, and Controls (CMC) is a crucial part of the drug development and manufacturing process to ensure consistent safety, efficacy, and quality of pharmaceutical products. Our European facility is GMP-certified and specializes in providing cell-based CMC potency assays in support of lot release and stability testing of therapeutics.
Off-the-shelf assays that are in place and available for rapid implementation in regulated or nonregulated sample analysis directly translate into faster timelines and reduced costs for our customers. We offer an extensive list of biomarkers as well as anti-drug antibody (ADA) and neutralizing antibody (NAb) assays that have been qualified or validated in various matrices and are ready for sample analysis. View our off-the-shelf assay menu.
PRESS RELEASE
BioAgilytix Accelerates Global Growth with LC/MS Investments Across Three Continents
BioAgilytix has advanced its growth strategy with multi-million-dollar investments in Liquid Chromatography–Mass Spectrometry (LC/MS) capabilities, including new platforms and expanded lab space in Hamburg, Germany and Durham, North Carolina.
State-of-the-art platforms for large molecule bioanalysis
We maintain an extensive suite of instrumentation at our Hamburg facility to ensure we can meet our customer’s wide-ranging bioanalytical needs. Some of our commonly utilized platforms in large molecule bioanalysis include:
ARTICLE
BioAgilytix: Your Comprehensive Bioanalytical Partner
With three decades in bioanalysis, BioAgilytix leverages technical expertise with a uniquely consultative approach
Partnering with BioAgilytix, the global leader in bioanalytical services—for pharmacokinetics, immunogenicity, biomarkers, and diagnostic testing—brings a commitment to timely, transparent communication and scientific rigor that goes beyond other CROs to deliver your therapeutic to market faster.
Ready to Start Your Project?
Our scientists are available to discuss your project and how our bioanalytical CRO can help you streamline the drug development process.